FDA Device

Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235

Hazard

There is an Increased potential for broken struts of the stents.

What You Should Do

Remedy

Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.

Products

Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
UPC
Lot 5570485

Units Affected

17 stent systems